Josh Craven

Last chance to register for our 23 April webinar on IVDR transition timelines extension. Join Alex Laan, Head of IVD Notified Body at BSI, as he provides an overview on key changes impacting IVDs while discussing the steps BSI is taking to support IVD manufacturers through applications and review processes. A Q&A session will also be hosted to answer major questions you may have. Register here: https://bit.ly/3Pa0RxC #BSI #MedicalDevices #IVDs #StepsTowardsIVDRTransition #Webinar

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🔍 What does it take to be a successful Pharmacovigilance Inspector?   Pharmacovigilance (PV) inspectors ensure that pharmaceutical companies adhere to regulatory requirements and maintain robust PV systems. Here are the key qualifications and skills needed for this important role:   Qualifications: 📍 Educational Background: A degree in life sciences, pharmacy, medicine, or a related field is typically required. 📍 Certifications: Relevant certifications such as Certified Good Pharmacovigilance Practices (GVP) Inspector or certification in Pharmacovigilance can be advantageous. 📍 Experience: At least 3-5 years of experience in pharmacovigilance, regulatory affairs, or a related field. Previous inspection experience is highly desirable. 📍 Regulatory Knowledge: Comprehensive understanding of global PV regulations, including ICH guidelines, EU regulations, and FDA requirements. Key Skills: 📍 Attention to Detail: Ability to meticulously review documentation and identify compliance issues. 📍 Analytical Thinking: Proficiency in analyzing data and making informed decisions based on findings. 📍 Communication: Strong written and verbal communication skills to articulate findings and recommendations clearly. 📍 Problem-Solving: Capability to identify root causes of non-compliance and suggest effective corrective actions. 📍 Organizational Skills: Ability to manage multiple inspections and deadlines efficiently. 📍 Interpersonal Skills: Excellent interpersonal skills to interact with various stakeholders and conduct interviews during inspections. 📍 Technical Proficiency: Familiarity with PV databases and electronic systems used for adverse event reporting and data analysis. 📍 Continuous Learning: Commitment to staying updated with the latest PV regulations and industry best practices. Responsibilities: 📍 Inspection Planning and Execution: Developing inspection plans, conducting on-site and remote inspections, and documenting findings. 📍 Risk Assessment: Evaluating the risk level of PV systems and processes. 📍 Reporting: Preparing comprehensive inspection reports with findings, risks, and recommendations. 📍 Follow-Up: Ensuring timely implementation of corrective and preventive actions (CAPAs) based on inspection findings. 📍 Training: Providing training and guidance to teams on regulatory compliance and best practices. Take your pharmacovigilance to the #NextLevel with us! 🚀   #NextPVUniversity #DrugSafety #PharmacovigilanceEducation #Healthcare #Medicine #Pharmacology #AIPharmacovigilance

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Regulatory update 🔔: The Medicines and Healthcare products Regulatory Agency has set out its artificial intelligence (AI) regulatory strategy which ensures patient safety and industry innovation into 2030. Take a look at this month's key regulatory updates relating to the #AdvancedTherapies industry in the May edition of our monthly Regulatory Round-up: https://lnkd.in/eR3kNcgK #CellTherapy #GeneTherapy #ATMPs

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Some upcoming deadlines for the Medical Device Industry, I am sure it has been a massive work in progress, are you ready? By 26th May 2024: Manufacturers must have a Quality Management System (QMS) compliant with Article 10(9) of the MDR and initiate a formal application with a notified body for MDR conformity assessment. By 26th September 2024: A formal agreement with a notified body must be signed, ensuring appropriate surveillance for legacy devices.

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Clinical studies will soon employ risk-based monitoring! See our in-depth guide to find out how RBM improves trial efficiency and safety. Read more: https://hubs.li/Q02yk_0q0 #CTMS #EDC #Safety #PV #eTMF #RTSM #ClinicalTrials #Cloudbyz #Pharmaceutical #Biotechnology #MedicalDevices #Diagnostics #AI #Salesforce

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Ensuring Pharmacovigilance Compliance: National Contact Person Services at £60/Hour Do you require a National Contact Person (NCP) for pharmacovigilance activities in the UK? We offer comprehensive NCP services to Marketing Authorization Holders (MAHs) at a competitive rate of £60 per hour. Our experienced personnel will ensure you meet all necessary pharmacovigilance obligations within the UK. What We Offer: Serve as your primary contact point for the Medicines and Healthcare products Regulatory Agency (MHRA). Oversee and coordinate pharmacovigilance activities within the UK. Facilitate communication between you and the MHRA regarding suspected adverse reactions. Maintain compliance with relevant UK pharmacovigilance regulations. Benefits of Our NCP Services: Cost-Effective: Our hourly rate provides a budget-friendly solution for your pharmacovigilance needs. Expertise: Our team possesses in-depth knowledge of UK pharmacovigilance requirements. Efficiency: We streamline communication and ensure timely responses to the MHRA. Peace of Mind: Focus on your core business activities while we handle pharmacovigilance compliance. Contact us today to discuss your specific requirements and learn more about how our NCP services can benefit your organization. Contact: Email: [email protected] #Pharmacovigilance #NCP #UKCompliance #ClinicalTrials #DrugSafety #HealthcareRegulations #PharmacoVigilance #DrugSafetyMonitoring #MedicationSafety #ClinicalResearch #PatientSafety #PublicHealth #AdverseReactions #DrugDevelopment #MHRA #UKPharma #UKRegulations #MedicinesSafety #NCPservices #PharmacovigilanceSupport #ComplianceSolutions #OutsourcingPharmacovigilance #MAHs #MarketingAuthorizationHolders #PharmaceuticalCompanies #ClinicalResearchOrganizations

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🚨 ⏰Important Update:SAHPRA ISO 13485 Certification Requirement Deadline: 01 April 2025 ⏰🚨 The South African Health Products Regulatory Authority (SAHPRA) has announced that starting from April 1, 2025, ISO 13485 certification will be a mandatory regulatory requirement for the issuance of medical device licenses. As we enter June 2024, there are only 9 months left until this crucial deadline. It is imperative for all our members involved in the medical devices and IVD industry to ensure compliance with this regulation to avoid any disruptions in their operations. Achieving ISO 13485 certification will not only align you with regulatory standards but also ensure the quality and safety of your medical devices. Stay compliant, stay ahead! #MedicalDevices #IVD #ISO13485 #SAHPRA #RegulatoryCompliance #QualityManagement

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The globally recognised ISO 13485 standard provides a framework for implementing a Quality Management System (QMS) to help businesses deliver medical devices which meet regulatory requirements and maintain consistently high quality. In addition to supporting regulatory compliance, this framework aims to assist businesses demonstrate their commitment to excellence, achieve customer satisfaction and gain access to lucrative global markets.  Learn more here: https://lnkd.in/e4aReWJ6 #ISO13485 #MedicalDeviceQuality #QualityManagementSystem #RegulatoryCompliance #BusinessGrowth

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How is the transition from Manual Processes to Automated Quality Management done right? At polygal ag, we've transformed manual quality processes into a fully automated digital powerhouse! Tackling the journey of digitalizing laboratory data and automating processes can be manageable with a proven and tailored methodology. We faced significant hurdles, such as: ➤ Company Culture: Manage the organizational change and ensure all team members are on board and adequately trained to adapt to new digital workflows. ➤ Daily Business: Another challenge was maintaining data integrity and compliance throughout the transition, which is critical in a regulated environment. However, we overcame these challenges with determination and the right action plan, paving the way for a successful digital transformation. 1LIMS proved to be the perfect solution for Polygal. They could customize their implementation to meet their unique needs, streamlining their workflows, improving data traceability, and enhancing regulatory compliance. Using Lean Six Sigma to assess and optimize Polygals's processes, the platform's methodical approach ensured a smooth transition with immediate benefits and minimal disruption. Post-implementation, Polygal witnessed: ⭐️ 78% reduction in human errors ⭐️ 32% increase in sample throughput ⭐️ 45% decrease in efforts related to quality data management 🟰 Up to 50% savings annually in operational costs For Polygal, the transition from manual to automated systems with 1LIMS was a game-changer. It meant: ➕ Faster and more reliable data handling ➕ Robust process control ➕ Paved the way for scalable growth. The integration capabilities of 1LIMS ensured seamless communication between different systems within the laboratory, enhancing efficiency and reliability. Polygal's success story is a testament to the transformative power of lab digitalization, and it can bring similar benefits to your organization. Are you ready to elevate your lab's operational efficiency and data management? Check out our detailed success story here, Polygal's 1LIMS Implementation, and start your transformation journey today: https://lnkd.in/eXAVSjPt Sindy Seidel Francesca Paganelli Jonas Greminger Philipp Osterwalder Jürg Müller Sandra Reisch Emanuel Greminger Ajten Memedalji

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📣 MHRA Update on Medical Device Regulatory Changes – What It Means for Industry 📣 The MHRA is moving forward with important regulatory updates for the medical device sector. Following recent discussions with government and stakeholders, key developments include: 📌 Post-Market Surveillance A new regulation focused on clearer guidelines for monitoring and reporting on devices post-market will be laid before Parliament by year-end. 📌 Pre-Market Statutory Instrument (SI) New measures to enhance patient safety are being developed, including: - Higher classification and scrutiny for certain devices. - Legal requirements for Unique Device Identifiers (UDI) to improve traceability. - Implant cards for patients to provide clarity on their devices. - Stricter rules on device claims to ensure alignment with approved uses. 📌 Global Regulatory Alignment The UK continues to lead efforts in harmonizing global standards, working with the IMDRF and exploring reliance on trusted regulatory frameworks to streamline product approvals and reduce duplication. 📌 IVD and Software Regulations There are plans to implement a risk-based approach for In Vitro Diagnostic devices (IVDs) and increase the scrutiny of software and AI-driven medical devices, reflecting the growing role of digital technologies in healthcare. These changes will require significant updates to compliance processes and regulatory frameworks. The increased focus on PMS, UDI, and AI/Software regulation means that companies will need to review and potentially overhaul their current practices to ensure they meet the new standards. This will also affect clinical investigations, safety protocols, and product claims. The evolving regulations will further increase the need for specialized Quality and Regulatory professionals across the industry. As companies prepare for these changes, there will be a growing demand for expertise in regulatory compliance, product monitoring, and the introduction of new technologies. The development and implementation of new systems and procedures will likely lead to new projects and resource allocation to ensure adherence to the updated frameworks. Having seen a drop off in demand for contractors over the past 12-18 months compared to previous years, I’m optimistic heading into 2025. We connect with top-tier QA/RA and Engineering talent every single day, making us your go-to partner for rapid resourcing. Get in touch when you need immediate, expert support.

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https://lnkd.in/dqZTbXZh, a renowned document management solutions provider for regulated industries, has reintroduced its Editable ISO 13485 Documents Toolkit. This comprehensive toolkit is designed to assist medical device manufacturers in implementing and maintaining an ISO 13485-compliant quality management system (MDQMS) for the design and manufacture of medical devices. 'The updated ISO 13485 Documents Toolkit offers a set of easily editable documents that meet the ISO 13485:2016 standard requirements,' stated a representative from https://lnkd.in/dqZTbXZh. 'This crucial resource helps businesses save time and money during the MDQMS implementation process by eliminating the need to start from scratch.' The ISO 13485:2016 Documentation Toolkit includes a wide range of templates, pre-made documents, and resources, such as an ISO 13485 Quality Manual, procedures, exhibits, blank formats, standard operating procedures (SOPs), process flow charts, an audit checklist, and a medical device file. Suitable for various organizations, including medical device manufacturers, contract manufacturers, design and development firms, and companies seeking initial certification or transitioning from previous ISO 13485 versions, the toolkit provides all the necessary tools and guidance to implement the standard effectively. Global Manager Group #iso13485 #medicaldevicequalitymanagementsystem #mdqms #qualitymanagementsystem

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UK MHRA Software as a Medical Device: "A set of instructions that processes input data and creates output data". MHRA will implement additional pre-market essential requirements for SaMD that attempt to align with the requirements of Regulation 2017 / 745, in particular GSPR 17. A key point for this is that the MHRA are considering that Artificial Intelligence is a subset of software, therefore consequently it falls under the defintion above. From the consultation, the government does not propose to define Artificial Intelligence as a Medical Device (AIaMD) or set specific legal requirements beyond those being considered for SaMD - due to risks of regulatory overprescription. Interesting times given the EU now have the AI Act and ISO 42001 have been published. Perhaps the UK Gov are looking into the EU to see how this plays out before making any concrete communications regarding specific legislation. Finally - the MHRA on the 30th April set out strategic approach to artificial intelligence which you can see here -https://lnkd.in/dDQivHfF #SAMD #UKMDR #RegulatoryAffairs #ArtificialIntelligence #MedicalDevices #MDR

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Let's talk QMSR / ISO 13485: 𝘊𝘰𝘳𝘳𝘦𝘤𝘵𝘪𝘰𝘯 versus 𝘊𝘰𝘳𝘳𝘦𝘤𝘵𝘪𝘷𝘦 𝘈𝘤𝘵𝘪𝘰𝘯 🤔 (Without stepping on the toes of Georg Digel - LinkedIn's CAPA Authority 🙌🏻 ) Comment 57 pointed out that the original draft of the QMSR 820.35(a)(6) required manufacturers to keep a record of any "corrective action" (but not "correction") related to Complaint Handling. The commenter went on to ask FDA to add the term "correction" to align with the 𝘤𝘶𝘳𝘳𝘦𝘯𝘵 requirement in ISO 13485, Clause 8.2.2 Complaint Handling: f) determining the need to initiate 𝗰𝗼𝗿𝗿𝗲𝗰𝘁𝗶𝗼𝗻𝘀 𝗼𝗿 corrective actions Happily, FDA agreed to add the term "correction" to harmonize with the standard 👍🏻 So 820.35 Control of Records now reads: (a) Records of complaints. In addition to Clause 8.2.2 in ISO 13485, Complaint Handling...the manufacturer must record the following information: (6) Any 𝗰𝗼𝗿𝗿𝗲𝗰𝘁𝗶𝗼𝗻 𝗼𝗿 corrective action taken Interestingly, FDA didn't adopt the "same" language as ISO but close enough 🎯😂 Since "correction" has never been in the QSR, do you believe FDA Investigators will require a learning curve on "correction" vs. "corrective action"❓ Or Do you believe ISO 13485 paved the way for this distinction and Investigators are already on board❓ ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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📢 𝗡𝗲𝘄𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗙𝗗𝗔! 👉 The 𝗙𝗗𝗔 today announced the final guidance for the ‘𝟱𝟭𝟬(𝗸) 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗮𝗻𝗱 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗨𝘀𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄’. 💡 This guidance details the processes, expectations and regulatory frameworks for third-party organisations authorised by the FDA to review medical device pre-market notifications (510(k)) and Emergency Use Authorisation (USA) applications. 🎯 The 510(k) Third Party Review Program, formerly known as the Accredited Persons (AP) Program, allows the FDA to recognise qualified third parties to conduct initial reviews of 510(k) submissions for low to moderate-risk medical devices. These reviews are conducted by 510(k) Third Party Review Organisations (3P510k ROs) under the supervision of the Center for Devices and Radiological Health (CDRH). 🤝 In addition, the FDA may contract with third-party review organisations to conduct reviews of USA applications (3PUSA) when the appropriate emergency declaration authorities are active. 🚨 This new guidance replaces the previous document issued on 12 March 2020. 🔎 Find out more about how Smart MDR can help your company achieve regulatory excellence at www.smartmdr.com #FDA #Regulation #MedicalDevices #510k #USA #SmartMDR Sandra Balseiro Celeste Oliveira Natalia de Souza Lescura Viviana Gomes @Luiz de Pádua Queiroz Júnior

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📢 𝗡𝗲𝘄𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗙𝗗𝗔! 👉 The 𝗙𝗗𝗔 today announced the final guidance for the ‘𝟱𝟭𝟬(𝗸) 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗮𝗻𝗱 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗨𝘀𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄’. 💡 This guidance details the processes, expectations and regulatory frameworks for third-party organisations authorised by the FDA to review medical device pre-market notifications (510(k)) and Emergency Use Authorisation (USA) applications. 🎯 The 510(k) Third Party Review Program, formerly known as the Accredited Persons Program, allows the FDA to recognise qualified third parties to conduct initial reviews of 510(k) submissions for low to moderate-risk medical devices. These reviews are conducted by(AP)510(k) Third Party Review Organisations (3P510k ROs) under the supervision of the Center for Devices and Radiological Health (CDRH). 🤝 In addition, the FDA may contract with third-party review organisations to conduct reviews of USA applications (3PUSA) when the appropriate emergency declaration authorities are active. 🚨 This new guidance replaces the previous document issued on 12 March 2020. 🔎 Find out more about how Smart MDR can help your company achieve regulatory excellence at www.smartmdr.com #FDA #Regulation #MedicalDevices #510k #USA #SmartMDR Sandra Balseiro Celeste Oliveira Natalia de Souza Lescura Viviana Gomes Luiz de Pádua Queiroz Júnior

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📢 𝗡𝗲𝘄𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗙𝗗𝗔! 👉 The 𝗙𝗗𝗔 today announced the final guidance for the ‘𝟱𝟭𝟬(𝗸) 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄 𝗣𝗿𝗼𝗴𝗿𝗮𝗺 𝗮𝗻𝗱 𝗘𝗺𝗲𝗿𝗴𝗲𝗻𝗰𝘆 𝗨𝘀𝗲 𝗔𝘂𝘁𝗵𝗼𝗿𝗶𝘀𝗮𝘁𝗶𝗼𝗻 𝗧𝗵𝗶𝗿𝗱 𝗣𝗮𝗿𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄’. 💡 This guidance details the processes, expectations and regulatory frameworks for third-party organisations authorised by the FDA to review medical device pre-market notifications (510(k)) and Emergency Use Authorisation (USA) applications. 🎯 The 510(k) Third Party Review Program, formerly known as the Accredited Persons Program, allows the FDA to recognise qualified third parties to conduct initial reviews of 510(k) submissions for low to moderate-risk medical devices. These reviews are conducted by(AP)510(k) Third Party Review Organisations (3P510k ROs) under the supervision of the Center for Devices and Radiological Health (CDRH). 🤝 In addition, the FDA may contract with third-party review organisations to conduct reviews of USA applications (3PUSA) when the appropriate emergency declaration authorities are active. 🚨 This new guidance replaces the previous document issued on 12 March 2020. 🔎 Find out more about how Smart MDR can help your company achieve regulatory excellence at www.smartmdr.com #FDA #Regulation #MedicalDevices #510k #USA #SmartMDR Sandra Balseiro Celeste Oliveira Natalia de Souza Lescura Viviana Gomes Luiz de Pádua Queiroz Júnior

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Interesting Read 🔖: This insightful article from Pharmaceutical Journal Publications details the adoption of a quality improvement approach to patient safety incidents. Read More: https://lnkd.in/eGUNRS4K For over 50 years serving the #compounding pharmacy, #IMI has improved patient safety through the design and manufacturing of innovative medical products that safeguard against #tampering and enhance pharmacy practices. See How: https://lnkd.in/ez9eMXyE

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Ever felt overwhelmed by all the documentation acronyms in medical device development? DHF, DMR, QMS—it’s a lot! But when it comes to DHF vs DMR, understanding the difference isn’t just helpful—it’s essential for compliance. At Fission, we know that navigating FDA requirements can feel daunting. The Design History File (DHF) and Device Master Record (DMR) are two foundational documents that every medical device company needs to get right. But what exactly do they cover, and why are they so important? In our latest blog, we break it all down: ➡️ The roles of the DHF and DMR. ➡️ How they work together to bridge design and manufacturing. ➡️ Practical tips for managing them effectively and staying audit-ready. The best part? With the right systems and processes, keeping these documents in check doesn’t have to be a headache. Ready to simplify your DHF and DMR management? Dive into our blog for actionable strategies: https://lnkd.in/gFWk5KTx

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